Withings BPM Core - Blood Pressure Monitor Manual

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Important notice

Before using Withings BPM Core, review the information in this guide:
Please contact Withings when in need of assistance, setting up, using or maintaining the device or to report unexpected operations or events. The user is an intended operator. Any serious incident that has occurred in relation to the Withings BPM Core should be reported to Withings and competent authorities in your country of residence.
In order to use your Withings BPM Core, you need an iOS (14.0 or higher) or Android (8.0 and higher) device to install it. Thereafter, the product can be used without your mobile device on you, thanks to the Wi-Fi and Bluetooth connections.

WITHINGS,
2 rue Maurice Hartmann,
92130 Issy-les-Moulineaux,
FRANCE
+33141460460

Distributed by Withings Inc.,
179 South Street, Floor 5
Boston, MA 02111 USA

Intended use

Withings BPM Core is a digital monitor intended for use in measuring blood pressure and heart rate, to record a one-lead ECG to detect atrial fibrillation, and to uncover valvular heart diseases (aortic stenosis, aortic regurgitation, mitral regurgitation). The device is intended to be used in a human adult population with an arm circumference of 9 inches to 17 inches (22 cm to 42 cm). Withings BPM Core is a medical device. Contact your physician if hypertensive values, atrial fibrillation (AFib) or VHD are indicated.

Types of measurements

Withings BPM Core allows you to take two types of measurements:

• Blood pressure and heart rate, which uses the cuff as a sensor.
• ECG and Heart Sounds recording, which uses three electrodes (two inside the cuff, the other on the metal tube) and the stethoscope (the circular white sensor on the cuff).

Before the measurement

Before the measurement, make sure that you:

• Choose a calm, quiet room to take the measurement.
• Ensure you have a chair, one with a back, and a table or armrest on which you can place your arm.
• Use the device on the left upper arm.
• Do not speak or move during the measurement.
• Wear only one layer of clothing, which should not cover your left arm. The electrodes should be in contact with the skin.

How to take measurements

1. Sit down in a comfortable position, legs uncrossed, feet flat on the floor, arm and back supported. Uncover your left arm. Rest for 5 minutes before the first measurement.
   
2. Tighten the cuff around your arm. The stethoscope should be facing the rib cage, with the metal tube facing down about one inch above the elbow.
   
3. For blood pressure measurement. Place your left arm on a table with the cuff level with your heart and your palm facing up. Make sure the cuff is not touching the left side of your chest. Your arm should be resting comfortably on the table without making any effort. Do not speak or move during the measurement.
   
4. For ECG and Heart Sounds recording:
   The excess cuff should not overlap the stethoscope. For this measurement, you should place the stethoscope in contact with your chest, and the two electrodes inside the cuff should be in contact with your skin. Make sure that the stethoscope is in contact with your chest during the measurement. Do not speak or move during the measurement. Breathe normally. You do not need to put your left hand on a table.
   

Standard mode

1. Two measurements in a row will be taken during this mode. The first one is a blood pressure measurement, which you should take in the position described above.
   The second is a combined measurement of an ECG and Heart Sounds recording via the stethoscope.
   
2. Push the button. The screen will display "START." Push the button once again to start the measurement. The blood pressure measurement starts.
3. When the screen displays the illustrated pictogram, it means that the blood pressure measurement is finished and that you will now proceed to the ECG and stethoscope signal recording. Adjust your arm position to place the stethoscope against your chest, and place your hand on the metal tube to ensure an accurate measurement.
   You can remove your hand from the table and follow the position described above.
   

Other measurement modes

1. When you push the button to start Withings BPM Core, you can also select "Start x3" or "ECG" by swiping the touch-sensitive area on the screen. "Start x3" launches three blood pressure measurements in a row followed by an ECG and stethoscope measurement. "ECG" will only record the ECG and stethoscope signals. Make sure to use the correct arm position for each measurement type.
   
2. If an error message appears on screen, please refer to the explanation displayed in the app and troubleshooting procedures.
   

LED color signification

The LED display on Withings BPM Core can be:
Blue: if Withings BPM Core has not been paired with a mobile device yet.
Green: for optimal and normal blood pressure measurements. The LED can also be green if Withings BPM Core has been paired with a mobile device.
Orange: for high normal blood pressure measurements. The LED can also be orange if Withings BPM Core has a low battery (you can still take a measurement) or if there is an error during one of the measurements during x3 measurement mode. During x3 mode, you may see a short ERROR display and orange LED, but afterward, it will give you the option to restart the measurement. If you fail to get a result on the second try, the LED will turn red.
Red: if hypertension (grade 1, 2, 3) or isolated systolic hypertension are detected. The LED can also be red if Withings BPM Core has no battery or if there is an error during the blood pressure or stethoscope measurement
Pink: if you press and hold the monitor's button for 6 seconds until the Settings menu opens and "Training" is displayed on the screen. The LED can also be pink when Withings BPM Core has been factory reset.

Note: The LED color displayed on the device may vary depending on the classification guidelines of your country. Please go to support.withings.com for more information on blood pressure measurement classification.

VHD detection

Information related to VHD detection is available in the Withings app.

ECG performance

Clinical performance
The ECG algorithm's ability to accurately classify an ECG into AFib and sinus rhythm was tested in a clinical trial of 115 subjects. Rhythm classification of a 12-lead ECG by a cardiologist was compared to the simultaneous classification of an ECG recorded by Withings BPM Core.

The ECG recording result on the mobile app provides a detailed display of the result.

Withings BPM Core outputs

Troubleshooting

If you cannot fix the problem using the following troubleshooting instructions, please contact Withings or go to: withings.com/support

Specifications & technical data

Product description: Automatic electronic blood pressure monitor with stethoscope, electrocardiogram and heart rate sensor.
Model: WPM04
Blood pressure measurement method: Cuff oscillometric method
Cuff inflation: Automatic inflation with air pump at 5 mmHg/s
Pressure sensor: Gauge sensor
Measurement range (pressure): 0 to 285 mmHg, DIA 40 to 130 mmHg, SYS 60 to 230 mmHg
Measurement range (pulse): 40 to 180 beats/min
Pressure sensor accuracy: Within +- 3 mmHg or 2% of reading
Clinical accuracy (blood pressure): Withings BPM Core performance in blood pressure measurement was validated in a clinical trial. The results are within the margin of acceptance defined by the internationally recognized evaluation standard of blood pressure monitors ANSI/AAMI/ISO 81060-2:2013, EN ISO 81060-2:2014 and AAMI/ ESH/ISO 81060-2:2018, developed by the European Society of Hypertension, British Hypertension Society and Association for the Advancement of Medical Instrumentation/American Heart Association. For more information, go to: withings.com/support
Accuracy (pulse): Within +-5% of reading
Sensor: Semiconductor pressure sensor
Operating conditions: 5 to 40°C, 15 to 90% RH, atmospheric 86Kpa~106kpa, altitude: 2000m
Storage and transport conditions: -25 to 70°C, 10 to 95% RH, atmospheric 86Kpa~106kpa, Max altitude: 2000m
Arm type: Use on left arm
Internal Power source: 3.6 VDC Lithium ion battery
Weight: Approx. 430g
Expected minimum product life: 3 years
Wireless transmission: Wi-Fi and BLE

Note: Specifications are subject to change without prior notice or any obligation on the parts of the manufacturer

After use

Cleaning

• Clean the device with a soft and dry cloth.
• Do not use an alcohol-based or solvent agent.
• Do not rinse the device and cuff with a lot of water.
• Do not submerge the device or any of the components in water.

Storage

• Store the device and the components in a clean and safe location.
• If storage conditions are different from the usage conditions indicated in this document, please wait 30 minutes before taking a measurement.

Maintenance

If you cannot fix the problem using the troubleshooting instructions, request service from your dealer. The manufacturer will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other information that will assist the manufacturer's staff or authorized representative with repair. It is generally recommended to have the device inspected every 2 years to ensure proper functioning and accuracy. Do not use the device while doing maintenance steps.

Symbols

IP22	Ingress of water or particulate matter
	Keep Dry
	Temperature limit
	Atmospheric pressure limitation
	Humidity limitation
	Type BF Applied Part (cuff)
	Direct current

Warnings and safety notices

• Do not forcibly bend the arm cuff.
• Do not inflate the arm cuff when it is not wrapped around your arm.
• Do not apply strong shocks and vibrations to the blood pressure monitor or drop it.
• Do not take a measurement after bathing, drinking alcohol, smoking, exercising or eating.
• Do not immerse the arm cuff in water.
• Do not use with a pacemaker, a defibrillator or other electric implant.
• Use on adults only.
• Do not use it on children or pets.

Consult your doctor during pregnancy, or if you suffer from arrhythmia and arteriosclerosis. Please read this section carefully before using this smart blood pressure monitor with ECG & digital stethoscope.

Always consult your doctor. Self-diagnosis of measurement results and self treatment are dangerous. People with severe blood flow problems or blood disorders should consult a doctor before using the blood pressure monitor. Cuff inflation can cause internal bleeding. Operational factors such as common arrhythmias, ventricular premature beats, arteriosclerosis, poor perfusion, diabetes, age, pregnancy, pre-eclampsia or renal disease can affect the performance of the automated sphygmomanometer and/or its blood pressure reading. This is a precision measuring device that may be understood by lay users, but should still be handled with care. Exposing the device to prolonged lint, dust or sunlight might reduce its life or damage it. A damaged cuff or sensor may lead to incorrect measurements. The USB port should only be used for charging the device. Parts in contact with the skin: cuff and electrodes. Measurements can be affected by extreme temperatures, humidity & altitude.

• Do not leave the blood pressure monitor unattended with infants. Strangulation may occur.
• Do not use the blood pressure monitor for any purpose other than measuring blood pressure, recording an ECG and recording heart sounds.
• Do not disassemble the blood pressure monitor.
• Do not operate the blood pressure monitor in a moving vehicle (car, airplane).
• Do not use the device with the USB cable plugged in.
• Do not shake the unit violently.

• Improper continuous pressure of cuff or too-frequent measurements may interfere with blood flow and result in injury to the user. Check to ensure that the use of the device does not result in prolonged impairment of your blood circulation.
• Do not apply the cuff over the user's arm if it has a wound or medical treatment, as this can cause further injury.
• Consult your physician before using this monitor if you have had a mastectomy.
• Use of the device can temporarily cause the loss of function of equipment that is used simultaneously on the same limb.
• Do not use if you have a congenital cardiomyopathy, aorto-venous fistula, pulmonary pathology, a prosthetic heart valve, if you are on kidney dialysis, or if you are hemodynamically unstable.
• There is a risk concerning Lead, PZT, DEHP, DBP, SCCP and D6 according to REACH regulation 1907/2006.

Need help?
withings.com/support

Manufacturer
WITHINGS, 2 rue Maurice Hartmann,
92130 Issy-les-Moulineaux,
FRANCE
+33141460460

Frequency band: 2402 - 2480 MHz 12822460
Maximum output power: 4.45 dBm

Australian sponsor:
Emergo Australia
Level 20, Tower II, Darling Park,
201 Sussex Street, Sydney, NSW 2000 Australia

Documents / Resources

Download manual

Here you can download full pdf version of manual, it may contain additional safety instructions, warranty information, FCC rules, etc.

Download Withings BPM Core - Blood Pressure Monitor Manual